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NCT00727064 · ClinicalTrials.gov registry record · Phase 1
Study Evaluating the Pharmacokinetics of Venlafaxine Extended-Release (ER) and Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg in Healthy Subjects
A Phase 1 study, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT00727064: Completed Phase 1 study, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
NCT00727064 is a Phase 1 study that has completed, run by Wyeth is now a wholly owned subsidiary of Pfizer. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00727064, a Phase 1 study, has completed, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if the relative difference in Pharmacokinetics (PK) between extensive metabolizers (EMs) and poor metabolizers (PMs) is the same with desvenlafaxine SR and venlafaxine ER when a single dose is administered.
Primary Outcome
Cmax is a measure of drug metabolism and presented as least squares geometric mean with 90% Confidence Interval. Variations in drug metabolism among individuals can be due to differences in genetic expression (phenotype) of Cytochrome P450 (CYP450) enzymes. Enzyme CYP2D6 has 4 metabolizer phenotypes: poor (PM), intermediate (IM), extensive (EM), and ultrarapid (UM) metabolizers.
Interventions
- DRUG Desvenlafaxine Succinate Sustained-Release (DVS SR)
- DRUG Venlafaxine Extended Release (VEN ER)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2008-06 |
| Est. Completion | 2008-08 |
| Phase | Phase 1 |
What the finished NCT00727064 record still lists
NCT00727064 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Desvenlafaxine Succinate Sustained-Release (DVS SR) is the first listed.
NCT00727064 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00727064 about?
NCT00727064 is a clinical study titled "Study Evaluating the Pharmacokinetics of Venlafaxine Extended-Release (ER) and Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg in Healthy Subjects". The purpose of this study is to determine if the relative difference in Pharmacokinetics (PK) between extensive metabolizers (EMs) and poor metabolizers (PMs) is the same with desvenlafaxine SR and venlafaxine ER when a single dose is administered.
What is the current status of trial NCT00727064?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2008-06. Estimated completion is 2008-08.
What interventions are being tested in trial NCT00727064?
The interventions under investigation include: Desvenlafaxine Succinate Sustained-Release (DVS SR) (DRUG), Venlafaxine Extended Release (VEN ER) (DRUG).
Who is sponsoring clinical trial NCT00727064?
This trial is sponsored by Wyeth is now a wholly owned subsidiary of Pfizer, which has 167 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00727064's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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